Does oral Lactobacillus therapy help in prevention of recurrent UTI as compared to oral antibiotic prophylaxis- A randomized controlled trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To see the rate of symptomatic UTIs (clinical recurrences (CR)) during the 3 months of therapy, as reported by the patient
研究概览
简要总结
Recurrent UTIs are emerging as a serious health concern in women. They are a common cause of morbidity in sexually active women, both pre and post-menopausal. It is known that depletion of vaginal lactobacilli is associated with UTI risk, hence, repletion may be beneficial. Recurrent UTI is defined as the occurrence of at least 3 episodes of UTI in the last 12 months or 2 episodes in the last 6 months. Studies show that one third of all women will have at least one episode of uncomplicated UTI by the age of 26 and amongst these around 25%-30% will have recurrence1. Due to factors such as decreased quality of life, growing antibiotic resistance, and increased treatment costs, studying and developing new management strategies with non-antibiotic therapies is much in need. Here, we aim to study the efficacy and safety of lactobacillus in the treatment of recurrent UTIs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients aged 18 years or above with culture-proven recurrent UTIs Written informed consent.
排除标准
- •1.Complicated cystitis 2.Uncomplicated pyelonephritis 3.A history of urologic abnormality or renal calculi 4.Recent sexually transmitted infections (STI) 5.History of recurrent Bacterial vaginosis 6.Risk factors for STI and human immunodeficiency virus (HIV) infection 7.Pregnancy or within 2 months of pregnancy 8.Lactation 9.Uncontrolled Diabetes (controlled would be enrolled) 10.Other immunocompromised states 11.Drug or alcohol abuse Abnormal pelvic examination results.
结局指标
主要结局
To see the rate of symptomatic UTIs (clinical recurrences (CR)) during the 3 months of therapy, as reported by the patient
时间窗: at presentation | at 1 month | at 3 months
次要结局
- a)To measure the number of microbiologically confirmed symptomatic UTIs (microbiologic recurrences) during the 3 months of prophylaxis.(at presentation)
- b)To compare the time to the first Microbiologic Recurrence (MR). An MR was defined as a UTI based on the combination of clinical symptoms and bacteriuria (103 CFU/mL bacteria in midstream urine).(at presentation)
- c)The most common causative microorganism in Indian women.(at presentation)
研究者
Dr Prasanna Ram
AIIMS